Device Classification Name |
Detector And Alarm, Arrhythmia
|
510(k) Number |
K140548 |
Device Name |
CORCAM HEART MONITOR |
Applicant |
CORCAM TECHNOLOGIA, SA |
575 EIGHTH AVE, STE 1212 |
NEW YORK,
NY
10018
|
|
Applicant Contact |
JENNIFER A DAUDELIN |
Correspondent |
CORCAM TECHNOLOGIA, SA |
575 EIGHTH AVE, STE 1212 |
NEW YORK,
NY
10018
|
|
Correspondent Contact |
JENNIFER A DAUDELIN |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 03/04/2014 |
Decision Date | 05/23/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|